OncoMatch/Clinical Trials/NCT04427293
Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC)
Is NCT04427293 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Lenvatinib and Pembrolizumab for triple negative breast cancer.
Treatment: Lenvatinib · Pembrolizumab — This is single arm study of a window of opportunity in which participants with previously untreated triple negative breast cancers (TNBC) who are candidates for potentially curative surgery will receive lenvatinib 12 mg daily for 7 and pembrolizumab 200 mg IV on day 1 prior to surgery
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 wild-type (≤10% of tumor cells staining for ER by IHC)
Estrogen Receptor (ER)- and Progesterone Receptor (PR)-negative as determined by immunohistochemistry (IHC)
Required: PR (PGR) wild-type (≤10% of tumor cells staining for PR by IHC)
Estrogen Receptor (ER)- and Progesterone Receptor (PR)-negative as determined by immunohistochemistry (IHC)
Required: HER2 (ERBB2) wild-type (HER2-negative, as defined by ASCO/CAP guidelines)
HER2-negative, as defined by ASCO/CAP guidelines
Disease stage
Required: Stage T1B-T3, N0-N3 (AJCC 8th edition)
AJCC 8th edition clinical stage T1b-T3/N0-N3/M0 by physical exam or radiologic studies
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: cytotoxic chemotherapy
Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy, radiotherapy directed towards the primary breast tumor and/or ipsilateral axillary lymph nodes or investigational agents) with therapeutic intent for the current breast cancer
Cannot have received: immunotherapy
Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy, radiotherapy directed towards the primary breast tumor and/or ipsilateral axillary lymph nodes or investigational agents) with therapeutic intent for the current breast cancer
Cannot have received: biologic therapy
Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy, radiotherapy directed towards the primary breast tumor and/or ipsilateral axillary lymph nodes or investigational agents) with therapeutic intent for the current breast cancer
Cannot have received: radiation therapy
Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy, radiotherapy directed towards the primary breast tumor and/or ipsilateral axillary lymph nodes or investigational agents) with therapeutic intent for the current breast cancer
Cannot have received: investigational agent
Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy, radiotherapy directed towards the primary breast tumor and/or ipsilateral axillary lymph nodes or investigational agents) with therapeutic intent for the current breast cancer
Cannot have received: VEGFR inhibitor (lenvatinib)
Previous treatment with lenvatinib or any immune checkpoint inhibitor within the past 2 years
Cannot have received: checkpoint inhibitor
Previous treatment with lenvatinib or any immune checkpoint inhibitor within the past 2 years
Lab requirements
Blood counts
Leukocytes ≥2,500/mm3; Platelet count ≥ 100,000/mm3; ANC ≥ 1,500/mm3; Hemoglobin (Hgb) ≥ 9.0 g/dL
Kidney function
Creatinine < 1.5 x ULN or CrCl ≥ 50 mL/min using Cockcroft-Gault formula
Liver function
Bilirubin ≤ 1.5 × ULN (Gilbert's syndrome exception); AST ≤ 2.5 × ULN; ALT ≤ 2.5 × ULN
Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 30 days prior to registration Hematological Leukocytes ≥2,500/mm3 Platelet count ≥ 100,000/mm3 Absolute Neutrophil Count (ANC) ≥ 1,500/mm3 Hemoglobin (Hgb) ≥ 9.0 g/dL Renal Creatinine/Calculated creatinine clearance (CrCl) Cr < 1.5 x upper limit of normal (ULN) or CrCl ≥ 50 mL/min using the Cockcroft-Gault formula Hepatic Bilirubin Bilirubin ≤ 1.5 × ULN. Subjects with Gilbert's syndrome may have a bilirubin > 1.5 × ULN, if no evidence of biliary obstruction exists Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Illinois · Chicago, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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